A Study of Quintuple Therapy to Treat COVID-19 Infection

Phase 2

Completed

• Conditions: COVID-19; Corona Virus Infection; Coronavirus-19; Sars-CoV2
• Interventions: Drug: Hydroxychloroquine; Drug: Azithromycin; Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc

• Registration Number: NCT04334512
• Lead Sponsor: ProgenaBiome

Brief Summary

This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).

Detailed Description

In this study patients will be treated with a combination therapy to determine if this combination can effectively treat COVID-19. Treatment will last ten days. The study will last 24 weeks.

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Study Start: 2020-06-22
• Status Verified: 2024-02
• Primary Completion: 2024-02-27
• Study Completion: 2024-02-27
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quintuple Therapy	Hydroxychloroquine	Patients will be treated with quintuple therapy for 10 days.
Quintuple Therapy	Azithromycin	Patients will be treated with quintuple therapy for 10 days.
Quintuple Therapy	Vitamin C	Patients will be treated with quintuple therapy for 10 days.
Quintuple Therapy	Vitamin D	Patients will be treated with quintuple therapy for 10 days.
Quintuple Therapy	Zinc	Patients will be treated with quintuple therapy for 10 days.
Placebo	Vitamin C	Patients will be treated with placebo.
Placebo	Vitamin D	Patients will be treated with placebo.
Placebo	Zinc	Patients will be treated with placebo.

Primary Outcome Measures

Name	Time	Method
The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy	12 weeks	Number of days from COVID-19 diagnosis to recovery via RT-PCR
Reduction or Progression of Symptomatic Days	12 weeks	Reduction and/or progression of symptomatic days, reduction of symptom severity
Assess the safety of Quintuple Therapy	12 weeks	Assess the symptom response to study therapy as measured by the survey in the EDC
Assess the safety of Quintuple Therapy via pulse	12 weeks	Pulse from baseline to 12 weeks
Assess the safety of Quintuple Therapy via oxygen saturation	12 weeks	Oxygen saturation from baseline to 12 weeks
Assess the safety of Quintuple Therapy via EKG	12 weeks	EKG response from baseline to 12 weeks
Assess Tolerability of Quintuple Therapy	12 weeks	Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States